Abstract: A pharmaceutical formulation and its process for the preparation of controlled release gastric floating matrix solid oral dosage form of lmatinib or its pharmaceutically acceptable salts and its polymorphs such as ~, a2, Form I and Form 2 thereof for once daily administration in the form of coated tablet or minitablets and / or pellets filled in hard gelatin capsules.
| Section | Controller | Decision Date |
|---|---|---|
| # | Name | Date |
|---|---|---|
| 1 | 1049-CHE-2004 OTHER DOCUMENT 11-08-2009.pdf | 2009-08-11 |
| 1 | 1049-CHE-2004_EXAMREPORT.pdf | 2016-07-02 |
| 2 | 1049-CHE-2004 FORM-2 17-08-2009.pdf | 2009-08-17 |
| 2 | 1049-CHE-2004 CORRESPONDENCE PO.pdf | 2011-12-02 |
| 3 | 1049-CHE-2004 FORM 1.pdf | 2011-12-02 |
| 3 | 1049-che-2004 description (complete)-17-08-2009.pdf | 2009-08-17 |
| 4 | 1049-che-2004 corrspondence others-17-08-2009.pdf | 2009-08-17 |
| 4 | 1049-CHE-2004 FORM 18.pdf | 2011-12-02 |
| 5 | 1049-CHE-2004 FORM 3.pdf | 2011-12-02 |
| 5 | 1049-che-2004 claims-17-08-2009.pdf | 2009-08-17 |
| 6 | 1049-CHE-2004 FORM 5.pdf | 2011-12-02 |
| 6 | 1049-che-2004 abstract-17-08-2009.pdf | 2009-08-17 |
| 7 | 1049-CHE-2004 CORRESPONDENCE OTHERS 19-03-2010.pdf | 2010-03-19 |
| 7 | 1049-CHE-2004 CORRESPONDENCE OTHERS 10-02-2011.pdf | 2011-02-10 |
| 8 | 1049-CHE-2004 CORRESPONDENCE OTHERS 19-03-2010.pdf | 2010-03-19 |
| 8 | 1049-CHE-2004 CORRESPONDENCE OTHERS 10-02-2011.pdf | 2011-02-10 |
| 9 | 1049-CHE-2004 FORM 5.pdf | 2011-12-02 |
| 9 | 1049-che-2004 abstract-17-08-2009.pdf | 2009-08-17 |
| 10 | 1049-che-2004 claims-17-08-2009.pdf | 2009-08-17 |
| 10 | 1049-CHE-2004 FORM 3.pdf | 2011-12-02 |
| 11 | 1049-che-2004 corrspondence others-17-08-2009.pdf | 2009-08-17 |
| 11 | 1049-CHE-2004 FORM 18.pdf | 2011-12-02 |
| 12 | 1049-CHE-2004 FORM 1.pdf | 2011-12-02 |
| 12 | 1049-che-2004 description (complete)-17-08-2009.pdf | 2009-08-17 |
| 13 | 1049-CHE-2004 FORM-2 17-08-2009.pdf | 2009-08-17 |
| 13 | 1049-CHE-2004 CORRESPONDENCE PO.pdf | 2011-12-02 |
| 14 | 1049-CHE-2004_EXAMREPORT.pdf | 2016-07-02 |
| 14 | 1049-CHE-2004 OTHER DOCUMENT 11-08-2009.pdf | 2009-08-11 |